Meet the Expert, Mats Govaerts

“The combination of IT and domain expertise sets you apart”

The Life Sciences sector in Belgium is undergoing rapid change. Innovations in data and AI offer new opportunities, but also present complex challenges, particularly in a highly regulated environment like Life Sciences. Mats Govaerts, AI Lead Life Sciences and IT Compliance Consultant at Sopra Steria, finds himself right at the intersection of technology, regulation and innovation. We spoke to him about his role, his career path and developments in the sector.

What does an AI Lead Life Sciences /IT Compliance Consultant do?
“My job is twofold. On the one hand, I work as an IT Compliance Consultant. This means helping pharmaceutical companies comply with regulations such as 21 CFR Part 11 from the Food and Drug Adminsistration (FDA), EU GMP Annex 11 and the GAMP 5 Guidelines. We translate that legislation into operational processes.” This involves activities such as drafting procedures, validating computerised systems and setting up governance structures.

At the same time, as AI Lead, I am responsible for devising, implementing and overseeing Sopra Steria’s AI strategy within the Life Sciences market. For example, we have developed several AI solutions that are currently undergoing validation for deployment within GxP-regulated environments. I lead these projects and support the adoption of AI solutions for the Life Sciences sector across our organisation.”

How did you end up in IT?
“My background is actually in the lab: I trained as a laboratory technician. While working for a biotechnology company, I realised just how much data was available and how many opportunities it presented. That motivated me to retrain in bioinformatics and data science. My interest in AI arose when the first publicly available large language models (LLMs) became accessible. I started experimenting with them straight away. On the recommendation of my girlfriend, who was already working at Sopra Steria and told me they have a large LS division, I got in touch with the company and it turned out to be a great fit. I really feel at home here.”

How long have you been working at Sopra Steria and why did you choose for this company?
“I’ve been working at Sopra Steria for about three years now. What particularly appeals to me is the freedom to develop yourself, develop ideas and demonstrate entrepreneurship. I’ve genuinely been able to do that here. I started as an IT compliance consultant and was then given the opportunity to help build up AI within the Life Sciences market. I launched an AI community, which over time evolved into an AI Competence Centre and has now become part of our market strategy.”

Can you give a practical example of your work?
“A significant part of our work involves conducting assessments. We analyse a client’s current processes and compliance structure and compare them against applicable regulations and industry requirements. Based on this, we advise where improvements are needed. We also advises in harmonising processes following mergers ansd acquisitions. The pharmaceutical industry sees a great deal of acquisition activity. Following an acquisition, companies often end up operating sites in several countries, each with its own way of working. We offer support to harmonise the different working methods and bring them together within a single, consistent structure. I am currently engaged with several clients, including at Curium, a producer of radiopharmaceuticals for diagnostic and therapeutic applications in nuclear medicine. There, we work at a global level and contribute strategically. For example, I helped set up the governance framework for IT compliance and data integrity.”

Which project are you most proud of?
“A project I’m really proud of is the development of an AI-powered tool for audit trail reviews. An audit trail records data changes, actions and workflows in a chronological and tamper-evident manner. It allows organisations to determine who changed what, when and why data has been changed. Audit trail reviews are among the most time-consuming data integrity activities in many organisations. They are a regulatory requirement, but reviewing them is often highly manual and labour-intensive. By applying AI, we automate and speed up this process, and reduce human error.”

At the same time, we are developing a broader validation approach for AI systems, enabling organisations to deploy them in a compliant manner. “If all goes according to plan, we hope to go live with this during the summer.”

What do you think are the biggest challenges in the Life Sciences sector?
“The biggest challenge facing the industry is striking the right balance between speed, innovation and compliance. Pharmaceutical companies want to accelerate digitalisation and deply new technologies such as cloud solutions and AI. However, every change must be documented, validated and fully aligned with regulatory requirements. This makes innovation more complex than in many other sectors. The challenge becomes even greater with AI, where technology is evolving at an extraordinary pace while organisations must simultaneously consider governance, validation and responsible use within GxP-regulated processes.”

What services and solutions can Sopra Steria offer?
“Our strength lies in combining deep expertise in Life Sciences regulations with the ability to implement digital solutions effectively. We not only understand how emerging technologies such as AI work, but also how to deploy them compliantly within a GxP-regulated environment. We can support clients throughout the entire journey, from strategy and governance to implementation, validation and operational support. This includes establishing quality management systems, supporting organisations during audits and developing tailored solutions. We even conduct mock audits, simulating official inspections to ensure clients are fully prepared.”

What recent developments are you seeing in the field of data & AI?
“AI is playing an increasingly significant role within the Life Sciences sector. We are seeing AI being applied more widely, for example to automate repetitive tasks such as audit trail reviews, the drafting of compliance documentation and the development of AI validation frameworks,” says Mats. “In addition, there is a clear shift towards cloud adoption and digitalisation. We are also seeing growing interest in Computer Software Assurance (CSA), where validation efforts are aligned with the level of risk to patient safety and product quality, placing greater emphasis on critical thinking and effective control mechanisms.”

What makes your work enjoyable?
“First and foremost, it’s my colleagues. I find the working culture at Sopra Steria particularly pleasant. Furthermore, it’s the combination of technology, regulation and impact that makes my work interesting. What we do in the field of computer system validation is ultimately intended to safeguard patient safety. Furthermore, you’re given the space here to develop ideas and grow professionally. When I joined, I didn’t have much experience as a consultant, but I was given the opportunity to set up an AI community and transform it into an AI Competence Centre, and now I’m involved in shaping the strategy.”

How do you stay on top of the latest developments?
“I attend lectures and conferences and keep a close eye on new legislation to stay up to date. With new regulations such as the EU GMP Annex 11, we often start preparing before they officially come into force, so that we can help clients immediately once the legislation is finalised. And last year, I completed a postgraduate course in AI compliance.”

What is your advice for people wanting to get into IT?
“Don’t just specialise in the technical side, but also choose a sector that interests you. In Life Sciences, knowledge of regulations is hugely valuable. The combination of IT and domain knowledge really sets you apart.”